A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension...

Date First Received: August 22, 2006

Last Updated: December 5, 2008

Verified by: Novartis, December 2008

Clinical Trial Phase: Phase 3 | Start Date: September 2006

Overall Status: Completed

Estimated Enrollment: 1325

Brief Summary

Official Title: “A 36 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active-Controlled, Optional Titration Study Comparing an Aliskiren-Based Regimen to a Ramipril-Based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension”

Condition Keyword(s):

Intervention(s):

Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

  • Drug: Aliskiren
    • 300 mg
  • Drug: Ramipril
    • Ramipril 10 mg

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Aliskiren 300 mg
  • Active Comparator: 2
    • Ramipril 10 mg

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from baseline in Mean Sitting Systolic Blood Pressure
    • Time Frame: 12 and 36 weeks
      Safety Issue?: No

Secondary Measures

  • Change from baseline in Mean sitting diastolic blood pressure (msDBP)
    • Time Frame: 12 and 36 weeks
      Safety Issue?: No
  • Frequency of Cough
    • Time Frame: 12 and 36 weeks
      Safety Issue?: Yes
  • Frequencies of Adverse Events
    • Time Frame: 12 and 36 weeks
      Safety Issue?: Yes
  • Change from baseline in the Psychological General Well-Being Index (PGWBI) and the Medical Outcomes Study (MOS) Sleep Scale (Short Form
    • Time Frame: 12 and 36 weeks
      Safety Issue?: No
  • Safety and tolerability
    • Time Frame: 12 and 36 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male or female outpatients 65 years old or older.
  • Patients with mild to moderate systolic hypertension.
  • Patients who are eligible and consent to participate in the study

Exclusion Criteria:

  • Severe hypertension
  • History of CVA, TIA, MI or bypass surgery in the last 6 months
  • Severe heart failure, severe chronic kidney disease or severe liver disease.
  • Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368277

Study ID Number: CSPP100A2344

ClinicalTrials.gov Identifier: NCT00368277

Health Authority: United States: Food and Drug Administration

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